(257 days)
No
The document describes a standard digital radiography system and its components. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The image processing system is described with basic functions like registration, acquisition, and processing, which are typical for such devices and do not inherently imply AI/ML.
No.
The device is intended for acquiring X-ray images for diagnostic purposes, not for treating or rehabilitating patients.
Yes
The device is intended for "acquiring X-ray images of the desired parts of patient's anatomy," which is a core function of diagnostic imaging.
No
The device description explicitly lists multiple hardware components including a portable X-ray Assembly, X-ray Protective Device, Mobile Stand, and Digital Detector. While it includes an image processing system, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for acquiring X-ray images of patient anatomy. This is an in vivo (within the living body) diagnostic imaging procedure, not an in vitro (outside the living body) test performed on biological samples.
- Device Description: The components described (X-ray assembly, detector, etc.) are all related to generating and capturing X-ray images of the body. There is no mention of reagents, assays, or analysis of biological specimens, which are characteristic of IVD devices.
- Input Imaging Modality: The input modality is X-ray, which is an in vivo imaging technique.
- Anatomical Site: The specified anatomical sites are parts of the human body, not biological samples.
IVD devices are used to examine specimens such as blood, urine, or tissue to diagnose diseases or other conditions. This device operates by sending X-rays through the patient's body to create images, which is a fundamentally different process.
N/A
Intended Use / Indications for Use
Intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).
This device is not intended for mammography and pediatric patients.
Product codes
IZL, MQB, LLZ
Device Description
This Digital Radiography System (ManntiX K) is a portable digital device developed, designed and manufactured by Shenzhen Browiner Tech Co., Ltd. A detailed comparison table with an equivalent device are in 510(k) summary. The device consists of the following major components: portable X-ray Assembly, X-ray Protective Device, Mobile Stand, Digital Detector, image processing system. The difference between ManntiX B and ManntiX K are as below. The major components of Digital Radiography System include: portable x-ray assembly, x-ray protective device, mobile stand, digital detector, image processing system, image acquisition workstation. Portable X-ray assembly including collimator and tube, produces X-rays at the clinically required dose; X-ray protective device is used to protect the human body during diagnostic radiography; mobile stand is used to support or hang X-ray source components; digital detector receives X-ray signals and converts them into visible light, which is converted into electrical signals by photoelectric elements and then converted into digital signals by analog-to-digital conversion before being transmitted to the computer; image processing system has multiple functions. including new patient registration, image acquisition and processing, data transmitting, etc; image acquisition workstation is used in addition to the image processing system to adjust exposure parameters, check the status of the entire machine, and view logs.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities
Indicated Patient Age Range
Not intended for pediatric patients.
Intended User / Care Setting
qualified/trained physician or technician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
December 9, 2024
Shenzhen Browiner Tech Co., Ltd % Long Yang COO Shenzhen Hlongmed Biotech Company 16th floor, Tianming Technology Building, No.8 Wushitou Road Songpingshan Community, Xili Street, Nanshan District Shenzhen, GD 518052 CHINA
Re: K240841
Trade/Device Name: Digital Radiography System (ManntiX B, ManntiX K) Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: Class II Product Code: IZL, MOB, LLZ Dated: November 5, 2024 Received: November 5, 2024
Dear Long Yang:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Digital Radiography System (ManntiX B, ManntiX K)
Indications for Use (Describe)
Intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).
This device is not intended for mammography.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(K) number is: K240841
1. Submitter
Shenzhen Browiner Tech Co., Ltd
Room 501, Building C, Ganghongji High-Tech Intelligent Industrial Park, No.1008, Songbai Road, Yangguang Community, Xili Street, Nanshan District, 518055 Shenzhen, PEOPLE'S REPUBLIC OF CHINA
2. Contact Person
2.1 Primarv Contact Person
Long Yang (COO)
Shenzhen Hlongmed Biotech Company
16th floor, Tianming Technology Building, No.8 Wushitou Road, Songpingshan Community, Xili Street, Nanshan District, Shenzhen, P.R.C
Tel: 0086-755-86664986
Fax: 0086-755-86664933
E-mail: yanglong@hlongmed.com
2.2 Secondary Contact Person
Li Chen(RA engineer)
Shenzhen Browiner Tech Co., Ltd
Room 501, Building C, Ganghongji High-Tech Intelligent Industrial Park, No.1008, Songbai Road, Yangguang Community, Xili Street, Nanshan District, 518055 Shenzhen, PEOPLE'S
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REPUBLIC OF CHINA
Tel: 0086-15752770581 Fax: 0086-755-22674695 E-mail: lichen@browiner.com
- Date Prepared: December 5, 2024
4. Proposed Device Information
Trade name: Digital Radiography System (ManntiX B, ManntiX K) Regulation Name: Mobile X-Ray System Classification name: System, X-Ray, Mobile Review Panel: Radiology Product Code:Primary Product Code: IZL; Secondary Product Code: MQB, LLZ Regulation Class: II Regulation Number: 21 CFR 892.1720
5. Predicate Device Information
| Manufacturer | Proprietary /Trade Name | 510(K) Number |
|---|---|---|
| Shantou Institute of | ||
| Ultrasonic Instruments | ||
| Co., Ltd. (SIUI) | SR-2300 Portable DR Imaging System | |
| SR-2300S Portable DR Imaging System | K202353 |
Device Name: SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System
Regulation Name: Mobile X-Ray System
Classification name: System, X-Ray, Mobile
Review Panel: Radiology
Product Code:Primary Product Code: IZL; Secondary Product Code: MQB, LLZ
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Regulation Class: II Regulation Number: 21 CFR 892.1720
6. Device Description
This Digital Radiography System (ManntiX K) is a portable digital device developed, designed and manufactured by Shenzhen Browiner Tech Co., Ltd. A detailed comparison table with an equivalent device are in 510(k) summary. The device consists of the following major components: portable X-ray Assembly, X-ray Protective Device, Mobile Stand, Digital Detector, image processing system. The difference between ManntiX B and ManntiX K are as below.
| Model | ManntiX B | ManntiX K |
|---|---|---|
| Portable X-ray Assembly (including collimator and tube) | PX10 | PX10 Pro |
| X-ray Protective Device (optional) | BA-01 | |
| Mobile Stand | MS-05P | MS-10P |
| Digital Detector (optional) | CareView 1500Cwe | |
| Mars1717X | ||
| Luna 1012X | ||
| Image Processing System (optional) | MOC (V03) | |
| Image Acquisition Workstation (optional) | BWS-10 |
Note:
-
- ManntiX B and ManntiX K are delivered with one of CareView1500Cwe, Mars1717X and Luna 1012X, or two of them, or three of them.
-
- A computer system, necessary for image viewing and manipulation, is not part of the device.
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The major components of Digital Radiography System include: portable x-ray assembly, x-ray protective device, mobile stand, digital detector, image processing system, image acquisition workstation.
Portable X-ray assembly including collimator and tube, produces X-rays at the clinically required dose; X-ray protective device is used to protect the human body during diagnostic radiography; mobile stand is used to support or hang X-ray source components; digital detector receives X-ray signals and converts them into visible light, which is converted into electrical signals by photoelectric elements and then converted into digital signals by analog-to-digital conversion before being transmitted to the computer; image processing system has multiple functions. including new patient registration, image acquisition and processing, data transmitting, etc; image acquisition workstation is used in addition to the image processing system to adjust exposure parameters, check the status of the entire machine, and view logs.
7. Intended use
Intended for use by a qualified/trained physician or technician for the purpose of acquiring Xray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).
This device is not intended for mammography and pediatric patients.
8. Comparison to Predicate Device
Radiography System have the similar intended use, use, similar The Digital technological characteristics as the following predicate device. Subject Device is substantially equivalent in its technologies and functionality to the SR-2300 Portable DR Imaging System/SR-2300S Portable DR Imaging System manufactured by Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) that is already cleared under premarketed notification number K202353.
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The details of the technological characteristics of the subject device ManntiX versus the predicate SR-2300 are as stated below:
| Item | Proposed Device | Predicate Device |
|---|---|---|
| Device Name | Digital Radiography System | SR-2300 Portable DR Imaging System |
| SR-2300S Portable DR Imaging System | ||
| Model | ManntiX B | |
| ManntiX K | SR-2300 | |
| SR-2300S | ||
| 510(k) number | K240841 | K202353 |
| Submitter | Shenzhen Browiner Tech Co., Ltd | Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) |
| Intended use | Intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities). | |
| This device is not intended for mammography and pediatric patients. | Intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities). | |
| This device is not intended for mammography. | ||
| Indications for use | Intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities). | |
| This device is not intended for mammography and pediatric patients. | Intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities). | |
| This device is not intended for mammography. | ||
| Basic | ||
| Generator | ||
| Characteristics | Peak generator | 5W |
| Maximum Power kW: 10 kW (100 mA, 100 kV) | ||
| Nominal Power kW: 8 kW (80 mA , 100 kV, 100 ms) | ||
| Tube current | 5-160 mA, ±20%. | |
| Contain the following mA slot: | ||
| 10-100mA | ||
| Item | Proposed Device | Predicate Device |
| 22, 25, 28, 32, 36, 40, 45, 50, 56, 63, | ||
| 71, 80, 90, 100, 110, 125, 140, 160 | ||
| Tube voltage adjustable range | 40-125kV, step value 1kV | 40-125kV, step value 1kV |
| mAs range | AC: from 0.1 mAs to 360 mAs, $\pm$ (10 % + 0.2 mAs). | |
| Contain the following mAs slot: | ||
| 0.1, 0.11, 0.125, 0.14, 0.16, 0.18, 0.2, | ||
| 0.22, 0.25, 0.28, 0.32, 0.36, 0.4, 0.45, | ||
| 0.5, 0.56, 0.63, 0.71, 0.8, 0.9, 1.0, 1.1, | ||
| 1.25, 1.4, 1.6, 1.8, 2.0, 2.2, 2.5, 2.8, | ||
| 3.2, 3.6, 4.0, 4.5, 5.0, 5.6, 6.3, 7.1, | ||
| 8.0, 9.0, 10, 11, 12.5, 14, 16, 18, 20, | ||
| 22, 25, 28, 32, 36, 40, 45, 50, 56, 63, | ||
| 71, 80, 90, 100, 110, 125, 140, 160, | ||
| 180, 200, 220, 250, 280, 320, 360 |
DC: from 0.1 mAs to 80 mAs, $\pm$ (10 % + 0.2 mAs).
Contain the following mAs slot:
0.1, 0.11, 0.125, 0.14, 0.16, 0.18, 0.2,
0.22, 0.25, 0.28, 0.32, 0.36, 0.4, 0.45,
0.5, 0.56, 0.63, 0.71, 0.8, 0.9, 1.0, 1.1,
1.25, 1.4, 1.6, 1.8, 2.0, 2.2, 2.5, 2.8,
3.2, 3.6, 4.0, 4.5, 5.0, 5.6, 6.3, 7.1,
8.0, 9.0, 10, 11, 12.5, 14, 16, 18, 20,
22, 25, 28, 32, 36, 40, 45, 50, 56, 63,
71, 80 | 0.4mAs-200mAs, with the range of:
0.40, 0.50, 0.63, 0.80, 1.00, 1.25,
1.6, ,2.0 ,2.5 ,3.2, 4.0, 5.0, 6.3, 8, 10,
12.5 ,16, 20, 25, 32, 40, 50, 63, 80,
100, 125, 160, 200 |
| Collimator | Built in | Built in |
| X-ray Generator | One model, up to 125kVp | One model, up to 125kV |
| Operator console | Button Control or Touch Screen | Button Control or Touch Screen |
| Digital X-Ray | Mars1717X (K210314) | SFD-1X |
| Detectors | CareView 1500Cwe (K201932) | |
| Item | Proposed Device | Predicate Device |
| Panel Shape | Mars1717X: Rectangular Panel
CareView 1500Cwe: Rectangular Panel
Luna 1012X: Rectangular Panel | Rectangular Panel |
| | | |
| | | |
| Detector Size | Mars1717X: 17"X17"
CareView 1500Cwe: 14"X17"
Luna 1012X: 10"X12" | 14"X17" |
| | | |
| | | |
| Pixel Pitch | Mars1717X: 100 μm
CareView 1500Cwe: 140 μm
Luna 1012X: 100 μm | 150 μm |
| | | |
| | | |
| Materials Scintillator | TFT -- amorphous Silicon | TFT -- amorphous Silicon |
| DQE | Mars1717X:
51% at 1.0 lp/mm
36% at 2.0 lp/mm
25% at 3.0 lp/mm | 36% at 1.0 lp/mm
13% at 3.0 lp/mm |
| | | |
| | | |
| | | |
| | CareView 1500Cwe:
43% at 1.0 lp/mm
30% at 2.0 lp/mm
15% at 3.0 lp/mm | |
| | | |
| | | |
| | | |
| | Luna 1012X:
51% at 1.0 lp/mm
36% at 2.0 lp/mm
25% at 3.0 lp/mm | |
| MTF | Mars1717X:
68% at 1.0 lp/mm
38% at 2.0 lp/mm
21% at 3.0 lp/mm | 38% at 2.0 lp/mm |
| | | |
| | | |
| | | |
| | CareView 1500Cwe:
60% at 1.0 lp/mm
32% at 2.0 lp/mm | |
| | | |
| | | |
| | | |
| Item | Proposed Device | Predicate Device |
| | 17% at 3.0 lp/mm | |
| | Luna 1012X:
68% at 1.0 lp/mm
38% at 2.0 lp/mm
21% at 3.0 lp/mm | |
| Communication | Wire | Wire |
| Method | Wireless | Wireless |
| | IEEE 802.11a/b/g/n/ac(2.4GHz/5GHz) | IEEE 802.11a/b/g/n (2.4GHz/ 5GHz) |
| | Security: WEP/WPA/WPA2 | Security: WEP/WPA/WPA2 |
| Components that can
communicate wirelessly | Digital Detectors | Digital X-Ray Detectors |
| Type of scintillator | Amorphous silicon | Amorphous silicon |
| Type of use | Removable detector | Removable detector |
| Effective imaging area | Mars1717X: 430 mm × 430 mm;
CareView 1500Cwe: 430 mm × 358 mm;
Luna 1012X: 315 mm × 250 mm.
Not less than 95% of the nominal
effective field of view | Not less than 95% of the nominal
effective field of view(430mm × 350mm). |
| Spatial resolution | Mars1717X: ≥5.0 lp/mm
CareView 1500Cwe: ≥3.6 lp/mm
Luna 1012X: ≥5.0 lp/mm | Not less than 3.6 lp/mm, without the
attenuator module. |
| Grayscale | 16 bit | Up to 16 bit. |
| Acquisition pixel | Mars1717X: 4267 × 4267
CareView 1500Cwe: 3072 × 2560
Luna 1012X: 3152 × 2502 | Not less than 2500 × 3052. |
| Imaging time | Mars1717X: No more than 12s.
CareView 1500Cwe: No more than
10s.
Luna 1012X: No more than 8s. | The fastest system imaging time is 8s. |
| Acquisition Software | MOC (V03) | PIE-5 |
| Software function | Image viewing
Image search
Image storage | Image viewing
Image search
Image storage |
| Item | Proposed Device | Predicate Device |
| | Image annotation | Image annotation |
| | Image measurement | Image measurement |
| | Image processing | Image processing |
| | Image stitch | Image stitch |
| DICOM 3.0
Compatibility | Yes | Yes |
| Photos | Image: Proposed Device Photo | Image: Predicate Device Photo
Note: The portable stand is an optional component. |
| Power Source | AC Line or rechargeable batteries | AC Line or rechargeable batteries |
| Standard | IEC 60601-1 | IEC 60601-1 |
| | IEC60601-1-2 | IEC60601-1-2 |
| | IEC60601-2-54 | IEC60601-2-54 |
| | IEC60601-1-3 | IEC60601-1-3 |
| | ISO 10993-1 | ISO 10993-1 |
| | IEC 62304 | IEC 62304 |
| | IEC 62366-1 | |
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9. Biocompatibility
The Digital Radiography System have been evaluated in accordance with Part 10993 of the International Standard Organization (ISO). Standard tests administered include:
• ISO 10993-1 Fifth edition 2018-08
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
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10. Summary of non-clinical performance Tests • IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
· IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
· IEC 60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
• IEC 60601-2-54 Edition 1.2 2018-06 CONSOLIDATED VERSION
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
· IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software -
Software life cycle processes
• IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION
Medical devices - Part 1: Application of usability engineering to medical devices
11. Substantial Equivalent Conclusions
Digital Radiography System has the similar intended use, similar technological characteristics as the predicate device. Moreover, non-clinical testing contained in this submission demonstrated that any difference in their technological characteristics does not raise any new issues of safety and effectiveness.
In conclusion, Digital Radiography System is substantial equivalent to the predicate device.